Cleared Special

K111060 - MRGFUS PELVIC PA COIL MODEL 1.0

K111060 is an FDA 510(k) clearance for MRGFUS PELVIC PA COIL MODEL 1.0, manufactured by Insightech, Ltd.. The device is a Class 2 Radiology device with product code MOS cleared through the Special 510(k) pathway after a 144-day FDA review.

K111060 · Insightech, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
144d
Days
Class 2
Risk

K111060 is an FDA 510(k) clearance for the MRGFUS PELVIC PA COIL MODEL 1.0. Classified as Coil, Magnetic Resonance, Specialty (product code MOS), Class II - Special Controls.

Submitted by Insightech, Ltd. (Tirat Carmel, IL). The FDA issued a Cleared decision on September 9, 2011 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1000 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111060

510(k) Number K111060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2011
Decision Date September 09, 2011
Days to Decision 144 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

MOS Device Classification - Class 2, Special Controls

Product Code MOS Coil, Magnetic Resonance, Specialty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1000
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MOS Coil, Magnetic Resonance, Specialty

All 489
Devices cleared under the same product code (MOS) and FDA review panel - the closest regulatory comparables to K111060.
CAROTID COIL
K112002 · Shanghai Chenguang Medical Technologies Co, Ltd. · Nov 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
K112293 · Time Medical Systems, Inc. · Sep 2011
4CH FLEX SPEEDER
K112366 · Toshiba Medical Systems Coporation, Japan · Sep 2011
TOSHIBA 3T EXTRA LARGE KNEE COIL
K112313 · Quality Electrodynamics · Sep 2011
SV BRAIN ARRAY, SIEMENS 3T
K111802 · Mri Interventions, Inc. · Sep 2011
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
K112112 · Sentinel Medical, Inc. · Aug 2011
K111060 · MRGFUS PELVIC PA COIL MODEL 1.0
Download PDF FDA Summary Insightech, Ltd.